NCT04654819

Brief Summary

The present study investigates confidence levels reported among intern dentists who used dental anesthesia simulators, before performing local anesthesia on patients as well as patient reports on intern dentist confidence levels to deliver anesthesia injections and compare them to those who did not receive dental anesthesia simulator education. Application success rates will also be investigated and compared. The study was carried out in the dental anesthesia simulator laboratory and in the faculty clinics of Ankara University, Faculty of Dentistry. A hundred volunteer intern dentists who completed the third year of the 5-year undergraduate education program and who had not performed local anesthesia on a patient contributed. Seventy intern dentists received training on dental anesthesia simulators, and made applications on patients, while 30 intern dentists made applications without training on the dental anesthesia simulators and served as control. With a prepared single questionnaire, intern dentists made self-assessment of preparedness and confidence, educators made assessment of application success rates and treated patients evaluated intern dentists' confidence levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

November 26, 2020

Last Update Submit

December 3, 2020

Conditions

Keywords

Dental anesthesiaDental educationSimulatorsTechnology

Outcome Measures

Primary Outcomes (2)

  • Self-reported preparedeness and confidence levels of intern dentists

    Intern preparedeness and confidence levels was assesed with a questionnaire answered by the intern dentists. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.

    2 years

  • Patients perception of intern dentist confidence levels

    Patients perception of intern dentist confidence was assesed with a prepared questionnaire answered by the patients. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.

    2 years

Study Arms (2)

Control group

NO INTERVENTION

This group made anesthesia application on patients without training on simulators.

Study group

EXPERIMENTAL

This group made anesthesia application on patients after training on simulators.

Device: Dental anesthesia simulator usage

Interventions

Training on dental anesthesia simulator

Study group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Intern dentists who had completed the third year of the 5-year undergraduate education program
  • Not applied local anesthesia to a patient
  • Consent to participate

You may not qualify if:

  • Applied local anesthesia to a patient
  • Not consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, 06940, Turkey (Türkiye)

Location

Study Officials

  • Cahit Üçok, Prof. Dr.

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The control group did not have access to simulators during the period of the study.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 4, 2020

Study Start

September 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations